Clinical trial
Esomeprazole (NEXIUM) vs. Surgery
NCT00251927 · AstraZeneca, Industry · Completed
Key facts
| NCT number | NCT00251927 |
|---|---|
| Title | Esomeprazole (NEXIUM) vs. Surgery |
| Official title | An Open, Randomized, Multicenter, Phase IIIB Study During 5 Years to Assess Long-term Efficacy and Tolerability of Esomeprazole Compared to Laparoscopic Anti-reflux Surgery in Adult Subjects With Gastroesophageal Reflux Disease - LOTUS. |
| Acronym | LOTUS |
| Lead sponsor | AstraZeneca, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Gastroesophageal Reflux |
| Intervention type | Drug, Procedure |
| Interventions | esomeprazole, Laparoscopic fundoplication (surgery) |
| Enrollment | 626 |
| Start date | Oct 1, 2001 |
| Primary completion | Apr 1, 2009 |
| Completion | Apr 1, 2009 |
| First posted | Nov 11, 2005 |
| Last update posted | Aug 8, 2012 |
| Countries | Austria, Belgium, Denmark, Finland, France, Germany, Iceland, Italy, Netherlands, Norway, Sweden, United Kingdom |
At a glance
- 10–99 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: